Events

Recall of Radiometer ABL90 Flex analysers running V3.1MR1 or below

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Radiometer Pacific Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00124-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-02-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00124-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    In december 2014 radiometer pacific advised their customers of a potential significant clinical issue with patient results processed on the abl90flex analyser if the inlet is left open for more than 30 seconds after aspiration of the patient sample (rc-2014-rn-01365-1). although the analyser provides warning sounds and messages the problem can occur after the following sequence of actions:1. the operator aspirates patient sample a and forgets to close the inlet 2. the inlet is left open for more than 30 seconds before it is closed3. an operator aspirates patient sample bin this case the results for patient sample b are affected by this issue.Radiometer pacific advised a short term corrective action by providing a warning label for attachment to the analyser. this label provided instructions for action if the inlet has been left open.
  • Action
    A Radiometer Pacific representative will perform a software upgrade to version 3.1 MR3 on your ABL90Flex analyser to correct the issue and to remove the warning label issued as part of the original recall action. The recall for product correction letter will be provided to customers when the correction is carried out onsite. This action has been closed-out on 12/08/2016.

Device

Radiometer ABL90 Flex analysers running V3.1MR1 or below

Manufacturer

Radiometer Pacific Pty Ltd